Clinical Data Coordinator I

Caris MPI, Inc.; Irving (TX); On-site; USD 64,000 - 72,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

401(k) match and financial planning

Paid time off

Job summary

Caris Life Sciences in Irving, TX seeks a Clinical Data Coordinator to ensure high data integrity for oncology trials across the Caris Precision Oncology Alliance sites. You will abstract data from source documents, enter into EDC forms, resolve data queries, and support QA audits while adhering to GCP, FDA, IRB, and HIPAA standards.

You will collaborate with on-site teams, manage site data timelines, and help maintain study documentation and data quality across protocols and projects.

Qualifications

• Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Experience handling oncology study data and terminology.
• Proficient in entering data into EDC systems and maintaining data quality.

Responsibilities

• Abstract clinical data from source documents.
• Enter data into study-specific EDC case report forms.
• Clean data and verify accuracy; update EDC after data verification.
• Track site goals and CRF completion; prioritize site cases for analysis.
• Maintain study documentation and perform QC audits of the database.
• Ensure compliance with GCP, FDA, IRB and HIPAA; adhere to SOPs.
• Collaborate with the onsite team to confirm proper consenting and data abstraction.
• Travel to multiple investigative sites if required; communicate with study personnel.

Skills

GCP/ICH knowledge

Oncology data terminology

Clinical data entry

EDC systems

Data integrity

Communication skills

Tools

EDC systems

Job description

At Caris, we understand that cancer is an ugly word—a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care—we’re changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: “What would I do if this patient were my mom?” That question drives everything we do. But our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare—driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you’re passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.

Position Summary

The Clinical Data Coordinator is responsible for clinical data entry activities for the Caris Medical Affairs protocols and projects at the Caris Precision Oncology Alliance sites. The position will ensure the highest standards for clinical data integrity and quality are maintained in alignment with critical research efforts aimed to improve the treatment, health and medical outcomes for oncology patients. Responsible for the collection and review of clinical protocol research data; Interpretation of data (including appropriate source documentation) for entry into computerized databases; Good understanding of data definitions and case report forms and other information related to data collection for clinical research. Must respond to queries in a timely fashion. Schedule on-site visits to perform data review and EDC data entry.

Job Responsibilities

• Abstract clinical data from subject source documentation.
• Enter clinical data into the study specific EDC case report forms.
• Clean the clinical data to verify accuracy.
• Update the EDC following verification of subject data, including the resolution of data queries.
• Track site goals and case report form completion.
• Prioritize site cases for analysis.
• Maintain study specific documentation.
• Perform QC audits of the clinical database.
• Support and adhere to Good Clinical Practices (GCP) guidelines, FDA, Institutional Review Board (IRB) and HIPAA regulations, Site Operating Procedures and ethical standards for the conduct of research clinical trials.
• Work closely with onsite team to confirm appropriate consenting is being performed and documented prior to data abstraction.
• Maintain to Caris and Site requirements for source document management and request for information.
• Act as site designated entry person.
• Willingness to travel to multiple investigative sites if required.
• Communicate effectively with the research team, investigator(s), Clinical Research Associate(s), study sponsor and ancillary staff.

Required Qualifications

• Position requires 3-5 years of experience in data collection activities within a GCP/clinical research regulatory environment.
• Knowledgeable in critical elements for success in clinical trials.
• GCPs, ICH, and Code of Federal Regulations.
• Clinical study experience in the field of Oncology.
• Strong medical terminology understanding.
• Experience in both small and large scale project planning and reporting with strong communication and presentation skills.
• Experience in providing training for both internal and external staff with a mentorship approach for less experienced colleagues.
• Experience with EDC systems.
• Proficient in Microsoft Office Suite, specifically Word, Excel, Outlook, and general working knowledge of Internet for business use.

Physical Demands

Must possess ability to sit and/or stand for long periods of time.

Training

All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

This position may require occasional evenings and overtime.

Annual Hiring Range

$64,000 - $72,000

Actual compensation offer to candidate may vary from posted hiring range based upon geographic location, work experience, education, and/or skill level. The pay ratio between base pay and target incentive (if applicable) will be finalized at offer.

Description of Benefits

Highly competitive and inclusive medical, dental and vision coverage options Health Savings Account for medical expenses and dependent care expenses Flexible Spending Account to pay for certain out-of-pocket expenses Paid time off, including: vacation, sick time and holidays 401k match and Financial Planning tools LTD and STD insurance coverages, as well as voluntary benefit options Employee Assistance Program Pet Insurance Legal Assistance Tuition Assistance

Conditions of Employment

Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Equal Opportunity Employment

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

About Caris Life Sciences

Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation.

Caris is committed to quality and excellence at our state‑of‑the‑art laboratories.

Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.